The SomniResonance® SR1 is a small, lightweight, battery operated, non-drug, non-invasive, safe, extremely low frequency (ELF), pulsed electromagnetic field generator. It utilizes a natural weak magnetic field strength of 50 milligauss which is approximately the average of the Earth’s magnetic field strength which ranges between 25-65 milligauss.
The SR1 has been designed specifically for the treatment of sleep disorders. It is attached over the brachial plexus (a nerve bundle in the chest) by a hypoallergenic, double-sided sticky disk. There are no electrodes, wires, wet sponges, ear clips or smartphones required.
Following a review of a 126-page application to market in the United States, the SomniResonance® SR1 was cleared for sale by the FDA in February 2015. The SR1 is UL Safety Certified (E464228) as a precision medical device specifically designed for the treatment of sleep disorders.
When an individual experiences difficulty falling asleep or staying asleep, it often means the normal frequency patterns of the brain are altered. By mimicking the normal frequency patterns of the brain in the process of falling asleep, the SomniResonance® SR1 gently encourages the brain to fall asleep.
Sleep is a heightened anabolic state; a period when our bodies are producing new bone, muscular and nervous tissue; a period when growth and repairs occur.
In 1953 it was discovered from electro-encephalographic recordings that the brain was not inactive during sleep. Decades of clinical and academic research have helped to identify the frequencies naturally produced by the brain during the process of falling asleep. The SomniResonance® SR1 mimics these frequencies, allowing the user to fall asleep more easily. It is not designed to keep the user artificially in any one stage of sleep but allows cycling through all the phases of sleep.
The copyright protected program in the SR1 runs for 22 minutes. The purpose of this is to gently retrain the brain to follow a natural sleep pattern. It is generally agreed that each full cycle of natural sleep lasts approximately ninety minutes (five cycles equals approximately 7.5 hours) and is made up of five stages. Stages 1 through 4 are described as non-rapid eye movement (NREM) sleep and stage 5 is rapid eye movement (REM) sleep. The cycles during the night are not equal. As we progress through the night the EEG associated with each cycle changes. Cycle 1 is different than cycle 3, cycle 2 is different than cycle 5 etc. Early prototypes of the SR1 utilized a frequency pattern that ran all night. This proved to be unsatisfactory. The brain was being led into an unnatural pattern and was not copying nature. The brain was being held in the same pattern over and over. The inventor of the SR1 and designer of the pattern wanted to encourage the brain to follow nature’s pattern.
“Normal” Percentage of Time in Each Stage of Sleep
The first thing we need to do here is define “normal”. “Normal” sleep requirements vary at different ages in our life. An infant’s normal pattern/requirement is far different than a septuagenarian’s normal sleep pattern.
We tend to use the term “normal” to describe the sleep pattern/requirements of an adult up to about age 45-50. Accepting this, the normal is as follows.
In a “normal” night’s sleep, Stage 2 (light sleep) accounts for 45-55% of the time asleep. REM sleep accounts for 20-25% of the time and stages 3 & 4 (deep sleep) for 20-25%. Stage 1 accounts for about 5%. As you see, stage 2 accounts for the largest percentage of time asleep.
It’s important to note that the largest percentage of deep sleep comes in the early part of the total night’s sleep pattern and accounts for only 1/5th to 1/4 of the total in the under 50 age group. The time spent in REM sleep increases in the later cycles of sleep. As we age our natural sleep pattern changes with less time spent in stages 3 & 4 (deep sleep). The older we get the amount of time spent in stages 3 & 4 reduces even further. This is nature’s way. The SR1 device is designed to copy nature.
Magnetic Field Strength
The SomniResonance® SR1 device generates a magnetic field strength of 50 milliGauss. This is a natural field strength and is around the average field strength of the Earth (25-65 milliGauss). Other technologies utilize an unnatural field strength of over 1 Tesla. 10,000 Gauss = 1 Tesla meaning, technologies utilizing 1 tesla are 200,000 times stronger than the SR1. This is well outside the realm of a low risk technology.
Success Rate
The SomniResonance® SR1 does not work for everyone. 82% of purchasers are satisfied with their purchase. Some clients have emailed the Company to say they have suffered from sleep disorders for many years. They have been taking pharmaceutical products or over the counter supplements all this time or they have tried a myriad of other remedies without positive results. They say they tried the SR1 for one night and it didn’t work. That is not a surprise. People with long term sleep disorders appear to have developed an aberrant frequency pattern which their brain has become accustomed to. The SR1 is designed to gently retrain the brain to follow a more normal pattern. This can take up to four weeks to achieve. Some have said the SR1 has disrupted the little sleep they were getting before using the device. The company views this as a positive step. The SR1 is altering the aberrant pattern and guiding the brain back to an effective sleep pattern. Most find if they stick with the program their quality of sleep will increase.
Some clients report their problem is in falling asleep. In the early use of the device some users need to restart the device maybe a couple of times. That is perfectly safe but it is important to allow the SR1 to run the full 22 minutes to get the full benefit of the frequency pattern. Others use the SR1 to quickly get back to sleep if they waken during the night. Business people who travel across time zones use the SR1 to help them sleep or take naps on planes.
Safety Certification is Important
Do you care whether the sleep technology you are considering is safety certified or has been cleared for sale by the FDA? Consider this; it’s called SAFETY certification for a reason. If a technology has not been certified as safe by an internationally recognized organization would you use it?
In November 2013, the Parent Company of the SomniResonance SR1 was informed the SR1 device had passed Underwriters Laboratories (UL) rigorous safety testing and was granted Medical Equipment Safety Certification number E464228.
In October 2014, the Company submitted an application to the FDA to be allowed to market the SomniResonance technology in the United States. In February 2015, notice was received from the FDA informing the Company the SR1 had been classified as “low risk” and that it had been cleared for sale in the U.S. The Company was also advised it could sell the device directly to the public for the treatment of sleep disorders without any requirement for a healthcare professional prescription or written recommendation.
Anyone considering purchasing a medical device should review the safety certification and FDA clearance or non-clearance of devices being considered.
A number of companies make “claims” in their promotional material but then have a “disclaimer” stating “they are not making medical claims, real or implied, as to benefit of their device and methods. Their product is not intended to be used to diagnose, treat, cure or prevent any disease”…or “their device is for experimental use only“.
The SR1 is cleared to make claims regarding sleep disorders. The SomniResonance SR1 is cleared by the FDA to treat sleep disorders.
The Company offers a 30-day trial period.
Written by Fraser W. Lawrie, Ph.D.
